Reducing severe maternal health risks in African American women with genital herpes
Comparative Effectiveness of Treating Genital Herpes Infection to Reduce Racial Disparities in the Risk of Severe Maternal Morbidity (SMM)
This study looks at how treating genital herpes in pregnant African American women can help reduce serious health risks for them and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 339000 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Kaiser Permanente Academic / other |
| Locations | 1 site (Oakland, California) |
| Trial ID | NCT05429346 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the racial disparities in severe maternal morbidity (SMM) among pregnant women, particularly focusing on African American women who are disproportionately affected by genital herpes simplex virus (GHSV) infection. The study will utilize a two-stage design, combining an electronic medical record-based cohort with a sub-cohort interview to gather comprehensive data on the impact of GHSV treatment on SMM risk. By understanding the relationship between GHSV infection and SMM, the study seeks to identify effective strategies to mitigate these disparities and improve maternal health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who are members of Kaiser Permanente Northern California.
Not a fit: Patients who are non-pregnant or not members of Kaiser Permanente Northern California may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for pregnant women with genital herpes, ultimately reducing the risk of severe maternal morbidity.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a correlation between GHSV treatment and reduced maternal morbidity, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Kaiser Permanente Northern California Members * Pregnant women Exclusion Criteria: * Non Kaiser Permanente Northern California Members * Non-pregnant women
Where this trial is running
Oakland, California
- Division of Research, Kaiser Permanente Northern California — Oakland, California, United States (Recruiting)
Study contacts
- Principal investigator: De-Kun Li, MD, PhD — Division of Research, Kaiser Permanente Northern California
- Study coordinator: Roxana Odouli, MSPH
- Email: Roxana.Odouli@kp.org
- Phone: 888.381.6818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.